The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Provisional opinion against authorization

6.—(1) Where the appropriate committee or the Medicines Commission are consulted under paragraph 5 and are of the provisional opinion that, on grounds relating to safety, quality or efficacy, they—

(a) may be unable to advise the licensing authority to grant or renew the authorization; or

(b) may be unable to advise the licensing authority to grant it unless it contains provisions otherwise than in accordance with the application; or

(c) may have to advise the licensing authority that the authorization ought to be revoked, varied or suspended,

the committee or Medicines Commission shall notify the applicant or holder accordingly.

(2) A person who has been notified in accordance with sub-paragraph (1) above may within the time allowed after the giving of the notification give notice of his wish to make written or oral representations to the appropriate committee or the Medicines Commission, as the case may be, and the committee or Medicines Commission, having given him an opportunity to make written or oral representations, shall take into acount such representations as are made.

(3) The appropriate committee or the Medicines Commission shall report their findings and advice to the licensing authority together with the reasons for their advice and the licensing authority shall take the report into account in deciding whether to grant the authorization, or to continue with the proposal to refuse to renew or to revoke, vary or suspend it.